Trial · NCT00446459
Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
NCT00446459, Phase 2, Completed, University of Washington; results first posted 2010-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant. Trials, record NCT00446459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00446459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
- NCT number
- NCT00446459
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Kidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal
- Interventions
- mycophenolate mofetil (CellCept)
- First posted
- 2007-03-12
- Last updated
- 2010-04-15
- Results first posted
- 2010-03-30
- Limitations and caveats
The treatment of highly sensitized patients on dialysis with single agent therapy of mycophenolate was hampered by gastrointestinal side effects that reduced anticipated maximum tolerated doses and duration of treatment.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Subjects With a 10% Decrease in PRA Level at Month 8. | Enrollment to month 8 | |
| Secondary | The Number of Subjects With Significant Infections up to Month 12. | From enrollment to month 12. | The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study. |
| Secondary | The Number of Kidney Transplant up to 12 Months. | Enrollment to month 8 or month 12 post enrollment. | The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study. |
| Secondary | The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL). | Enrollment to month 12. | The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months. |
| Secondary | The Number of Transplants With a Negative Crossmatch at Transplant. | Number of Transplants with a Negative Crossmatch. | The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | The Number of Subjects With Significant Infections up to Month 12. | From enrollment to month 12. | Forty five subjects were screened, of these 37 received MMF. | Participants | NUMBER |
| PRIMARY | The Number of Subjects With a 10% Decrease in PRA Level at Month 8. | Enrollment to month 8 | Participant | NUMBER | |
| SECONDARY | The Number of Kidney Transplant up to 12 Months. | Enrollment to month 8 or month 12 post enrollment. | Participants | NUMBER | |
| SECONDARY | The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL). | Enrollment to month 12. | Participant | NUMBER | |
| SECONDARY | The Number of Transplants With a Negative Crossmatch at Transplant. | Number of Transplants with a Negative Crossmatch. | Participant | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Subjects With Significant Infections up to Month 12. | Mycophenolate Mofetil (MMF) Single Arm Study | 4 | Participants | ||
| The Number of Subjects With a 10% Decrease in PRA Level at Month 8. | Mycophenolate Mofetil (MMF) Single Arm Study | 9 | Participant | ||
| The Number of Kidney Transplant up to 12 Months. | Mycophenolate Mofetil (MMF) Single Arm Study | 3 | Participants | ||
| The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL). | Mycophenolate Mofetil (MMF) Single Arm Study | 0 | Participant | ||
| The Number of Transplants With a Negative Crossmatch at Transplant. | Mycophenolate Mofetil (MMF) Single Arm Study | 0 | Participant |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 8 Months | STARTED | Mycophenolate Mofetil (MMF) Single Arm Study | 34 | |
| 8 Months | COMPLETED | Mycophenolate Mofetil (MMF) Single Arm Study | 22 | |
| 8 Months | NOT COMPLETED | Mycophenolate Mofetil (MMF) Single Arm Study | 12 | |
| 12 Months | STARTED | Mycophenolate Mofetil (MMF) Single Arm Study | 22 | |
| 12 Months | COMPLETED | Mycophenolate Mofetil (MMF) Single Arm Study | 4 | |
| 12 Months | NOT COMPLETED | Mycophenolate Mofetil (MMF) Single Arm Study | 18 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Peritonitis | Infections and infestations | Mycophenolate Mofetil (MMF) Single Arm Study | 2 | 37 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Mycophenolate Mofetil (MMF) Single Arm Study | 3 | 37 | 3 |
| other | Abscess | Infections and infestations | Mycophenolate Mofetil (MMF) Single Arm Study | 2 | 37 | 3 |
| serious | Myocardial infarction | Cardiac disorders | Mycophenolate Mofetil (MMF) Single Arm Study | 1 | 37 | 1 |
| serious | Retinal stroke | Cardiac disorders | Mycophenolate Mofetil (MMF) Single Arm Study | 1 | 37 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mycophenolate Mofetil (MMF) Single Arm Study | ||
| Total, other adverse events | Mycophenolate Mofetil (MMF) Single Arm Study | 6 | 37 |
| Total, serious adverse events | Mycophenolate Mofetil (MMF) Single Arm Study | 2 | 37 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00446459
GET https://conductscience.org/api/trials/v1/NCT00446459/registered